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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS123
Date Received04/29/2013
Decision Date05/29/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
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